Print

Purpose

The purpose of this research is to study the feasibility of a specific training program for the breathing muscles (inspiratory muscle training) and the effects on how breathing is regulated during exercise in typically developing children.

Condition

Eligibility

Eligible Ages
Between 6 Years and 12 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Age range 6-12 years of age

Exclusion Criteria

  • History of neuromuscular, cardiac, or pulmonary disease - Known intellectual or developmental problems that would preclude the ability to assent - Ruptured eardrum - Recent injury or condition (less than 6 months ago) that precludes strength testing or walking - Recent (less than 2 weeks ago) or current respiratory or other type of illness

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Inspiratory Muscle Training (IMT) 		Participants will be asked to perform inspiratory muscle training (breathing exercise) 5 days per week for 6 weeks at home.
  • Device: POWERbreathe Plus IMT
    Inspiratory muscle training will be performed using the POWERbreathe Plus IMT (POWERbreathe International Ltd., Warwickshire, UK), a commercially available inspiratory pressure threshold device. In this type of training, airflow is occluded until the generated inspiratory pressure reaches the predetermined threshold, which can be set at increments of 8 cm H2O. During the first week of training, the target intensity will be set at 50% of baseline maximal inspiratory pressure (MIP.) During the second week, the target intensity will be set at 60% of baseline MIP. Beginning at the third week and for the remainder of the training program, the target intensity will be set at 75% of the participant's baseline MIP. The target volume will be 5 sets of 6 breaths per day (total of 30 breaths per day), separated by 1-minute rest breaks between sets. The frequency of training will be 5 days per week, for a duration of 6 weeks.

Recruiting Locations

University of Maryland, Baltimore
Baltimore, Maryland 21201

More Details

Status
Recruiting
Sponsor
University of Maryland, Baltimore

Study Contact

Martina Miller
410-706-3869
martina.miller@umaryland.edu

Detailed Description

During the first study visit, participants will undergo a series of pulmonary function and muscle performance tests followed by treadmill walking trials at different speeds with concurrent expired gas analysis via a face mask. The participants will then perform a training program for the breathing muscles at home for 6 weeks. The research team will follow up each week via telehealth visits to support training. After the 6-week training program, participants will return in-person for a follow-up visit and will undergo the same series of assessments as the first visit.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.